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Recruiting NCT07635186

A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B

Phase II Interventional Chronic Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AHB-137, Placebo.
Who it may be relevant to
Registry conditions: Chronic Hepatitis B. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.

Overview

This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.

Interventions

  • Drug AHB-137
    AHB-137 will be administered subcutaneously.
  • Drug Placebo
    Placebo will be administered subcutaneously.

Primary outcome measures

  • HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment. [Time frame: Up to 48 weeks.]
  • Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment. [Time frame: Up to 48 weeks.]
Secondary outcome measures (12)
  • HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment. [Time frame: Up to 48 weeks.]
  • HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment. [Time frame: Up to 48 weeks.]
  • HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment. [Time frame: Up to 48 weeks.]
  • HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment. [Time frame: Up to 48 weeks.]
  • HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment. [Time frame: Up to 48 weeks.]
  • Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment. [Time frame: Up to 48 weeks.]
  • HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit. [Time frame: Up to 48 weeks.]
  • HBsAg, HBeAg seroconversion rates by visit. [Time frame: Up to 48 weeks.]
  • Test Values of Virological Parameters. [Time frame: Up to 48 weeks.]
  • Time to first achievement of HBsAg and first HBeAg seroconversion. [Time frame: Up to 48 weeks.]
  • Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline. [Time frame: Up to 48 weeks.]
  • Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline. [Time frame: Up to 48 weeks.]

Eligibility criteria

Inclusion criteria

  • Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.
  • Aged 18-65 years (including boundary values).
  • Body mass index between the range of 18-32 kg/m2 (inclusive boundary values).
  • HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.
  • HBsAg and HBV DNA values met protocol requirements at screening.
  • ALT < 3xULN at screening.
  • Use highly effective contraception as required.

Exclusion criteria

  • Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
  • Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.
  • Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.
  • Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).
  • Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening.
  • Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.
  • Laboratory test results do not meet the criteria.
  • Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.
  • Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.
  • Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
  • Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
  • Participants are participating in another clinical trial or failing to wash out as required.
  • Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.
  • Participants that require regular long-term anticoagulants.
  • Abnormal thyroid function.
  • Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
  • Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 34 centers
  • AusperBio Investigational Site — Beijing
  • AusperBio Investigational Site — Chongqing
  • The Second Affiliated Hospital of Chongqing Medical University — Chongqing
  • AusperBio Investigational Site — Xiamen
  • AusperBio Investigational Site — Guangzhou
  • AusperBio Investigational Site — Guangzhou
  • AusperBio Investigational Site — Guangzhou
  • AusperBio Investigational Site — Jiangmen
  • … and 26 more centers

Identifiers

NCT: NCT07635186 · AB-10-8016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗